Part I – Regulatory Requirements and Setting Specifcations during the Development Phase
Basic Principles for Setting of Release and Shelf-life Specifications
- Some basic statistics: Distribution and Variation
- Variation and specifications
- Changes over time and shelf life specification
- Process Capability
- Control strategy
- QbD or not to be
Current Regulatory Requirements for Setting Specifications (ICH Q6A)
- Regulatory overview
- Impact of pharmacopoeial provisions
- Setting specifications for active substances and finished products
- Justification of specifications
- Changes/variations
- Introduction to the requirements of risk assessment with focus on setting specifications for heavy metals
- How authorities will proceed in respect of submitting the required documentation for approved marketed products
Specifications of Biopharmaceuticals
- Overview of regulatory requirements
- Critical Quality attributes and Control Strategy
- Differences between NCEs and NBEs
- Considerations for Drug Substance and Drug Product
- Specifications during early and late stage development
- Acceptance criteria at release and for shelf life
Organic Impurities and Degradation Products with Special Emphasis on Genotoxic Impurities
- What do the guidelines tell us
- Impurity identification and profiling
- Impurity tracking
- Toxicological qualification
- Genotoxic impurities
- Control of genotoxic impurities
Part II – Chemical APIs and Biopharmaceutical Drug Development
Parallel Session A (Lectures and Workshops)
CHEMICAL APIs
Group I: APIs Manufactured by Chemical Synthesis
Lecture and Workshop
Rational Development and Justification of API Specfications
- In this workshop participants will elaborate specifications comprising typical tests for APIs:
- Assay, organic impurities and degradation products, water, residual solvents, heavy metals, particle size distribution, polymorphs, genotoxic impurities etc.
BIOLOGICALS
Group II: Drug Substances / Drug Products Manufactured by Biotechnological Processes – Part 1
Lecture and Workshop
Setting Specifications in early Biopharmaceutical Drug Development (with a special focus on Monoclonal Antibodies)
- General overview of manufacturing processes for biopharmaceuticals and process control
- Analytical testing scope for biopharmaceuticals
- How to set specifications: principles to consider and justification
Part III – Specific Considerations during Development and for Specific Dosage Forms
Setting Specifications throughout Drug Development
- Specifications throughout development
- Specifications in Pharmacopoeias
- Stability of the manufacturing process
- Specifications for comparator products
Specifications for Specific Drug Products – What is the Difference to Standard Formulations
- Specific aspects required for special drug products, e.g.
- Gastro-intestinal therapeutic systems (GITS) or osmotic-controlled release oral delivery systems (OROS)
- Transdermal patches
- Orally inhaled and nasal drug products (OINDPs)
Part IV – Drug Products and Biological Impurities
Parallel Session B (Lectures and Workshops)
DRUG PRODUCTS
Group I: Drug Products Containing APIs (manufactured by chemical synthesis)
Lecture and Workshop
Rational Development and Justification of Drug Products Specifications
- In this workshop participants will elaborate specifications comprising typical tests for different types of drug products, e.g. assay, purity, content uniformity, dissolution, fill volume, endotoxines, sterility etc.
BIOLOGICALS
Group II: Drug Substances / Drug Products Manufactured by Biotechnological Processes – Part 2
Lecture and Workshop
Impurities in Biological Drug Substances and Drug Products (with a special focus on Monoclonal Antibodies)
- Impurities from chemical synthesis versus biotechnological process
- Definition of impurities and their classification: productrelated impurities, process-related impurities, contaminants and identification of possible degradation products
- How to deal with impurities in biological drug substances and drug products
- Analytical techniques and other aspects
Part V – Common Technical Document (CTD)
Setting Specifications in the CTD
- Total Control Strategy and Regulatory background
- Drug Substances, Excipients and Drug Products
- Packaging materials
- Which information should be included in the CTD
- Typical questions from authorities and answers
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
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Current ICH and CHMP Guidelines for Stability Testing
- Overview of Stability Guidelines
- Concepts of Stability testing
- Retest period and Shelf-life
- Post-marketing Stability Studies
- Future Activities
Stability Testing for Biologicals
- Overview of regulatory requirements
- Types of stability studies for Biopharmaceuticals
- Practical aspects of stability studies with Biopharmaceuticals
- Degradation pathways
- Setting shelf life during early and late stage development
Stability Testing throughout Drug Development
- Must the development stability programme meet ICH Q1A?
- Stability testing from early development to product launch
- Clinical stability for comparators
- Site specific stability
Stability Testing for Drug Substances
- Stability protocols
- Stress testing
- Photostability testing
- Documentation
Stability Testing for Drug Products
- Strategy of Stability Testing
- Performance of new Drug Products
- Related Finished Products with existing substances
- Follow-up Stability Testing
Submitting Stability Data
- Regulatory Strategy Stability
- Drug Substance and Drug Product Stability Data and Evaluation
- Storage recommendations/labelling/SmPC
- Stability studies, commitments post approval
- Typical questions from authorities and answers
Evaluation of Stability Results – Statistical Considerations
- Sample number and replication
- Trend analysis
- Outliers
- Pooling of batch data
- Shelf life prediction